MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-05-31 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[146676861]
Sobstyl, m. , alksandrowicz, m. , zabek, m. , pasterski, t. Hemorrhagic complications seen on immediate intraprocedural stereotactic computed tomography imaging during deep brain stimulation implantation. Journal of the neurological sciences (2019): 400; 97-103. Doi: 10. 1016/j. Jns. 2019. 01. 033. Age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: patient sex was not identified in the article. Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature. Concomitant medical products: product id: 3389, lot #: unknown product type: lead. Product id: 3389, lot #: unknown product type: lead. Other relevant device(s) are: product id: 3389, serial/lot #: unknown. Product id: 3389, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146676862]
Summary: the authors present their operative experience of patients with movement disorders who developed intracerebral hemorrhage (ich), which was identified on intraprocedural stereotactic computed tomography (ct) imaging performed immediately after deep brain stimulation (dbs) lead placement and prior to the implantation of further components of the dbs hardware. Patients who underwent dbs lead implantation from january 2009 through december 2017 were included in the present study. Most of the surgeries were performed in a staged fashion. All patients were operated using identical surgical and intraprocedural imaging techniques, and no microelectrode recordings were done. Leksell stereotactic g frame and neuronavigation software was utilized for all surgeries. Intraprocedural stereotactic ct was performed to confirm the precise position of the implanted dbs lead and to rule out any hemorrhagic complications. Overall, 222 patients underwent 322 dbs lead implantations during 316 stereotactic procedures. Six patients exhibited early ich recognized on intraprocedural stereotactic ct performed immediately after dbs lead placement; in addition, two patients developed delayed ich due to large venous infarction. Four patients with ich were asymptomatic. The ich rate was 2. 5% per electrode and 3. 6% per patient; the permanent deficit rate was 1. 2% per electrode and 1. 8% per patient. The death rate due to ich in the cohort was 0. 6% per electrode and 0. 9% per patient. Intraprocedural stereotactic ct can not only visualize the implanted dbs lead in the stereotactic space but also rule out early ich. Identified predisposing factors for development of ich include patient's age, hypertension, and previous antiplatelet therapy. Careful planning of stereotactic trajectories plays a paramount role in reducing the rate of ich in dbs surgery. Reported events: two patients implanted with dbs for dystonia had electrodes re-implanted over follow-up due to breakage of the extracranial lead. Two patients implanted with dbs for dystonia had electrodes re-implanted over follow-up due to the suboptimal clinical benefit. The following device information was identified in the article: lead model 3389; ins models 37602, 37603, 7426.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2019-01208 |
| MDR Report Key | 8659126 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-05-03 |
| Date Added to Maude | 2019-05-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2019-05-31 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-05-31 |